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| Name | Class |
|---|---|
| MagicTime Medicine | INDUSTRY |
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This is an investigator-initiated, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of MTM-H-001 in adult participants with relapsed/refractory (R/R) B-cell malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Part A: Dose Escalation Part, MTM-H-001 Injection, 4 dose groups are planned. The study treatment period includes an induction phase and a maintenance phase. Part B: Dose Expansion Part, MTM-H-001 Injection, 3 dose cohorts are planned. The dose and frequency for each cohort will be determined based on the safety, PK, and PD data of participants from the dose groups in Part A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MTM-H-001 Injection | Drug | Each participant receives MTM-H-001 Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose-Limiting Toxicity (DLT) | Percentage of participants experiencing DLTs | 42 days following first dose of MTM-H-001 for each participant |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Percentage of participants who achieve complete response (CR) and partial response (PR) (evaluated by the investigator according to the criteria of Lugano 2014 and iWCLL 2018). | Throughout the study, up to 24 months |
| Disease control rate (DCR) |
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Inclusion Criteria:
Male or female, aged 18 - 75 years old (inclusive);
The participant or his/her legally acceptable representative gives consent to this clinical study participation and signs an Informed Consent Form (ICF) indicating their understanding of the objectives and procedures of the clinical study and willingness to participate in the study;
Participants with histopathologically and immunohistochemically confirmed Non-Hodgkin B-cell Lymphoma (B-NHL) according to the 2016 World Health Organization (WHO) classification of tumors of hematopoietic and lymphoid tissues (CLL/SLL diagnosed in accordance with 2018 iwCLL criteria)
Relapsed or refractory disease after receiving at least two prior lines of standard therapy, or relapsed or refractory disease after receiving autologous hematopoietic stem cell transplant (ASCT) (if applicable).
Adequate major organ function, defined as meeting the following criteria:
Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2;
Expected survival >3 months;
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and agree to use at least one effective contraceptive method throughout the study and within 6 months after the last treatment cycle.
Exclusion Criteria:
B-NHL participants with a history of Richter's transformation of chronic lymphocytic leukemia (CLL).
Primary central nervous system (CNS) lymphoma, or malignant tumors involving the CNS.
Burkitt's lymphoma/leukemia, primary mediastinal large B-cell lymphoma (LBCL).
Known history of other malignancies within the past 5 years, excluding cured localized tumors (including cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ, etc.);
Active hepatitis B virus (HBV) infection;
Active hepatitis C virus (HCV) infection;
Active human immunodeficiency virus (HIV) infection or a past history of HIV infection;
Uncontrolled active infection requiring intravenous treatment within one week prior to the first dose;
Corrected QT interval using Fridericia (QTcF) is ≥450 ms (male) or ≥470 ms (female) according to the electrocardiography (ECG) examination results at screening;
Currently experiencing or having experienced within the past 6 months any of the following:
History of any mental disorders (e.g., schizophrenia, bipolar disorder, eating disorders, major depression, or anxiety) as reported by the participant or documented in medical records;
Pregnant or breastfeeding women.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Green | Contact | 716-474-6710 | michaelgreen@magictimemed.com |
| Name | Affiliation | Role |
|---|---|---|
| Ning Li, Ph.D | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Langfang | Hebei | 065000 | China |
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Percentage of participants who achieve complete response (CR), partial response (PR) and stable disease (SD). |
| Throughout the study, up to 24 months |
| Time to response (TTR) | Time from the first dose of MTM-H-001 to the first documented response (CR or PR). | Throughout the study, up to 24 months |
| Duration of response (DOR) | Time from the first documented objective response (CR or PR) to the first documented progressive disease (PD) or death from any cause (whichever occurs first). | Throughout the study, up to 24 months |
| Event-free survival (EFS) | Time from the first dose of MTM-H-001 to the first documented PD or relapse, initiation of any new anti-lymphoma treatment, or death from any cause (whichever occurs first). | Throughout the study, up to 24 months |
| Progression free survival (PFS) | Time from the first dose of MTM-H-001 to the first documented PD or death from any cause (whichever occurs first). | Throughout the study, up to 24 months |
| Overall survival (OS) | Time from the first dose of MTM-H-001 to death from any cause. | Throughout the study, up to 24 months |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016393 | Lymphoma, B-Cell |
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